bortezomib

Generic: bortezomib

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bortezomib
Generic Name bortezomib
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

bortezomib 3.5 mg/1

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-337
Product ID 55150-337_107c9155-9130-4202-b2e4-4c7732561420
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212825
Listing Expiration 2026-12-31
Marketing Start 2022-05-02

Pharmacologic Class

Established (EPC)
proteasome inhibitor [epc]
Mechanism of Action
proteasome inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150337
Hyphenated Format 55150-337

Supplemental Identifiers

RxCUI
402243
UPC
0355150337019
UNII
69G8BD63PP
NUI
N0000175604 N0000175075

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bortezomib (source: ndc)
Generic Name bortezomib (source: ndc)
Application Number ANDA212825 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-337-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-337-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-337-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bortezomib (3.5 mg/1)

Linked Drug Pages (2)

BORTEZOMIB ndc-match (0.9) BORTEZOMIB ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "107c9155-9130-4202-b2e4-4c7732561420", "openfda": {"nui": ["N0000175604", "N0000175075"], "upc": ["0355150337019"], "unii": ["69G8BD63PP"], "rxcui": ["402243"], "spl_set_id": ["76c7c3a5-fd2f-403f-85fd-65a64538eee7"], "pharm_class_epc": ["Proteasome Inhibitor [EPC]"], "pharm_class_moa": ["Proteasome Inhibitors [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-337-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-337-01", "marketing_start_date": "20220502"}], "brand_name": "BORTEZOMIB", "product_id": "55150-337_107c9155-9130-4202-b2e4-4c7732561420", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proteasome Inhibitor [EPC]", "Proteasome Inhibitors [MoA]"], "product_ndc": "55150-337", "generic_name": "BORTEZOMIB", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BORTEZOMIB", "active_ingredients": [{"name": "BORTEZOMIB", "strength": "3.5 mg/1"}], "application_number": "ANDA212825", "marketing_category": "ANDA", "marketing_start_date": "20220502", "listing_expiration_date": "20261231"}